Preliminary results
appear promising warranting further research in a larger study.

Myoblast
cell sheets derived from the patient's skeletal
muscle in the thigh and grafted onto the heart surface have
shown encouraging results including improved heart function and exercise
tolerance and could be a viable option to treat heart failure,
according to a team of Japanese scientists.

Reason For the Study

Novel Therapy For Cardiomyopathy : Patientís Own Thigh Muscle Cells

The
research team feels that existing therapies for heart failure
including medications, pacemaker
implantations or even heart transplants are not effective or viable longterm options. Rather, they feel that muscle regenerative treatment using the patient's
own skeletal muscle cells might be a safe and feasible longterm
option.

‘Cell-sheet transplant as single line treatment for cardiomyopathy shows promise, especially in the face of severe shortage of donor hearts for transplant.
’

Methods of the Study

A
total of 27 patients suffering from
cardiomyopathy from various causes, were enlisted for this Phase I Clinical
Study. They were found to have heart failure (New York Heart Association
functional class†II†or†III) with reduced heart function and
limited exercise capacity, and had received maximum possible therapy without much
improvement.

In
this scenario, the research team transplanted
scaffold free muscle cell sheets derived from the patient's own thigh muscle on
to the surface of the patient's heart by means of a surgical procedure. No
other interventions were made as part of the treatment.

Findings of the Study

All
the patients were tracked over the
year following the transplant. The notable findings
included the following.

The procedure was safe with no major complications from
the procedure. Specifically no serious heart rhythm disturbances (arrhythmias)
were noted in the patients.

There was marked improvement in heart function with better exercise capacity including better performance in the Six-Minute
Walk Test which tests exercise
capacity.

Levels of B-type
natriuretic peptide (BNP) levels went down. BNP is a hormone secreted by
heart, the levels of which increase in heart
failure and decrease when heart function improves.

Left
ventricular stress decreased and left
ventricular function improved notably.

What is Cardiomyopathy?

Cardiomyopathy is a disease of the
heart muscle which affects the ability of the heart to effectively pump blood.
With progression, the patient develops shortness of breath, chest pain,
swelling of legs and feet, and severe limitation of routine activities. With
progression of the disease, the patient goes into heart failure.

With
major advances in stem cell research in the last decade, various cell therapies
have been tried hoping to regenerate heart muscle cells. The notable
observations emerging from stem cell research in relation to heart muscle
regeneration have been the following.

Cell therapy is a safe, albeit
modestly effective in improving heart function, probably due to certain
chemicals released by these cells that exert a slight local (paracrine) effect
on the heart tissue to improve its function.

Embryonic stem cells may be a better option but ethical issues surrounding their
use is a major stumbling block in stem cell research.

Goal
of future research should involve use of endogenous stem cells that are capable
of differentiating into heart muscle cells.

Additionally,
studies have shown that cell-sheet transplant on to the surface of the heart is
more effective than cell injections in maximizing the paracrine effect exerted
by them to improve heart function.

Use of scaffolds for
tissue regeneration have been found to be associated with complications such as
inflammatory response, biodegradability and compatibility issues.

Gaining
experience from previous studies and research, the current study used the patient's
own thigh muscle (endogenous) cells to generate skeletal myoblast cell
sheets.
Also they transplanted (avoiding injections which were not as effective)
scaffold free cell sheets onto the surface of the patients heart surgically.

In
conclusion, the results of the current study seem highly encouraging and
justify further follow-up of patients and
conducting larger trials to establish the efficacy of autologous muscle
cell-sheet transplant in the treatment of heart failure due to cardiomyopathy.

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